The present invention relates, in general, to the repair of defects in tissue and includes a novel surgical method for placing a surgical element into tissue with a surgical instrument. More particularly, to the method of use of the surgical fastening instrument and surgical fastener in combination with a prosthetic for the repair of an inguinal hernia.
It is established practice in the surgical field to repair defects in tissue, for instance, an inguinal hernia, through the use of PROLENE(trademark) mesh (manufactured and sold by Ethicon, Inc., Somerville, N.J.). Generally the mesh is cut to a desired size for placement over the inguinal hernia. Once the sized mesh has been placed over the defect, the mesh is attached to the surrounding inguinal tissue using several known attachment means.
Once the mesh is in place, it is important that the mesh serve as a barrier over the defect in order to restrict the lower viscera in the patient""s abdomen from protruding through the defect. Accordingly, it is essential that the attachment means used to secure the mesh to the inguinal tissue have an initial strength of several pounds of force in both the tensile and shear directions. Moreover, it is important that the mesh remain in place for several days so that natural adhesions can form to ensure that the mesh is sufficiently anchored to the tissue.
One common way of attaching the mesh to tissue is through the use of suture and needle. As would be expected, the suturing technique for this procedure requires a great deal of skill and is normally conducted by very experienced surgeons, especially for minimally invasive or laparoscopic procedures. Since the learning curve for laparoscopic suturing is extremely steep, many surgeons are slow to adopt this technique.
In response to the challenges associated with suturing, other fastening techniques have evolved such as the use of a surgical element or surgical fastener. Accordingly, it is now common practice to use a surgical stapler such as the ENDOSCOPIC MULTI-FIRE STAPLER(trademark) , (manufactured and sold by Ethicon Endo-Surgery, Inc., Cincinnati, Ohio). U.S. Pat. No. 5,470,010 by Robert Rothfuss et al. and in U.S. Pat. No. 5,582,616, also by Robert Rothfuss et al. disclose disposable endoscopic staplers of this type. These staplers are used to place a number of staples at various locations of the placed mesh in order to properly secure the mesh to the tissue. Although the endoscopic stapler is efficient and easy to use for a surgeon, the shaft diameters are on the order of 10 mm in diameter. Some surgeons believe that a smaller diameter instrument is better for endoscopic procedures and have begun to use smaller 5 mm devices that offer a reduced access incision in the abdomen and slightly better visibility.
In addition to using surgical staplers to secure mesh to inguinal tissue to repair a hernia, other types of fasteners have been developed. One of these fasteners is a helical fastener such as disclosed in U.S. Pat. No. 5,582,616 by Lee Bolduc et al., U.S. Pat. No. 5,810,882 by Lee Bolduc et al., and in U.S. Pat. No. 5,830,221 by Jeffrey Stein et al. A plurality of helical wire fasteners are stored serially within the 5 mm shaft, and are corkscrewed or rotated into tissue to attach the mesh. However, although these types of fasteners are also easy to use and decrease the procedure time, the long length and sharp end of the fastener can be an issue in thin tissue.
Other surgical fasteners and surgical application instruments have been tried for example plastic or stainless steel dart fastener having a pointed distal end with retaining barbs, and a large disk at the proximal end. A single shot plunger type applicator is used, and for multiple firings, a rotary magazine is employed. This type of fastener and surgical fastening instrument can be found in U.S. Pat. No. 5,203,864 (Edward Phillips). To apply, the surgeon drives the pointed end into the mesh patch and into tissue. Whereas the dart fasteners appear to be effective in fastening mesh to tissue, they have not gained acceptance within the surgical community possibly due to their single shot capabilities and the large size of the rotary magazine.
Another plastic fastener is the xe2x80x9cHxe2x80x9d shaped clothing tag fastener. This a fastener is best known for attaching tags to clothing. The fasteners are placed into tissue with a single shot instrument. The instrument and fastener are described in U.S. Pat. No. 5,290,297 by Edward Phillips. These fasteners and instruments are also relatively unknown by surgeons, possibly due to their single shot capabilities.
It is important to note that, presently, the known devices or attachment means for repairing tissue defects are endoscopic staplers, helical fastening instruments, fasteners, or simple needle and suture. Presently, there are no known surgical fastening methods that pierce tissue with the surgical instrument, and deliver a surgical element or fastener into tissue. Additionally, there are no known hernia fastening devices that place a blunt fastener into tissue. Also, it would be desirable for the surgical element or fastener to be used as a marker that can appear on MRI examinations, X-rays, or ultrasound. Thus, there are no known surgical fastening instruments or fastening methods that can meet all of the needs outlined above.
A method for delivering a plurality of individual surgical fasteners includes the steps of providing a surgical fastener delivery device. The delivery device has a drive mechanism having a distal and a proximal end, and a first and a second opposing member. The members are moveable proximally and distally with respect to the delivery device, and individually with respect to each other. The delivery device further includes a plurality of surgical fasteners located between the first and the second members. Next, the surgical fastener delivery device penetrates tissue by moving the drive mechanism distally. A distal end of one of the fasteners is partially deployed by moving the first member proximally. Finally, the distal end of the fastener is fully deployed by moving the second member proximally.